The number of patients with lower extremity varicose veins has been increasing due to an aging population, with treatments divided into conservative and invasive methods. Current treatments can be expensive and inaccessible for some patients. Entelon, a relatively inexpensive intravenous drug, has shown promise in improving symptoms related to venous lymphatic dysfunction, but its objective vascular function improvement hasn't been proven. This study aims to assess the effectiveness of Vitis Vinifera seed extract (Entelon®) combined with lifestyle therapy in patients with varicose veins, using follow-up Doppler ultrasonography to measure venous reflux improvement.
Varicose veins in the lower extremities are more than the function of the valve membranes on the inside of the legs, and the heart cannot function, resulting in regurgitation in the lower half of the body. This causes blood to pool in the lower extremities and causes various symptoms. Large stalks of superficial veins and venous valves of deep veins become dysfunctional, resulting in an increase in blood vessels in the calf area with backflow of blood. The valvular insufficiency of lower extremity veins is the main cause. In general, it occurs in the great saphenous vein that flows into the deep vein from the groin, the small saphenous vein in the posterior leg, and the perforating vein in the calf. Reflux in superficial veins (e.g. great saphenous vein, small saphenous vein) and deep veins can generally be confirmed using Doppler ultrasound. Determine the direction of treatment by confirming if there is branch vein dilatation. Ultrasonography is also done on the opposite, unaffected side, even if symptoms are in only one leg. Treatment of varicose veins can generally be divided into conservative treatment and invasive treatment, and lifestyle correction and wearing compression stockings are recommended as conservative treatment. Surgical treatment is indicated when conservative treatment is ineffective or interferes with daily life. Symptoms can be alleviated by removing superficial veins with regurgitation due to valvular insufficiency, or by inducing hardening of the causative blood vessels using high frequency or laser to block regurgitation and prevent blood flow. However, most of these treatments are non-salary items, and are relatively expensive treatment methods that impose a large financial burden on patients. In addition, deep veins are responsible for 90% of blood transport, but surgical treatment is impossible and only conservative treatment is possible. As a non-invasive treatment, which is an intravenous active agent, is registered as a drug to be administered, and improvement of symptoms related to venous lymphatic dysfunction (pain, lower extremity anxiety symptoms) is attracting attention. It is relatively inexpensive compared to surgical treatment, but until now, objective improvement of vascular function by drug treatment has not been proven. Vitis Vinifera seed extract (Entelon®) was launched in 1998 and its safety has already been confirmed, and the investigators have investigated the effect of lower limit volume reduction compared to placebo after administration of Vitis Vinifera seed extract in patients with edema. (Sano A, Tokutake S, Seo A. Proanthocyanidin-rich grape seed extract reduces leg swelling in healthy women during prolonged sitting. J Sci Food Agric. 2013 Feb;93(3):457-62.). In this study, along with lifestyle therapy in patients with varicose veins, follow-up Doppler ultrasonography after administration of Entelon will be used to confirm the improvement effect of venous reflux.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Administer 150mg of Vitis Vinifera seed extract (Entelon®) orally twice a day
Implementing TLCs is a critical component of a comprehensive treatment plan for varicose veins. A key aspect of TLCs is the optimization of postural habits. Patients are advised to avoid extended sitting or standing periods, which exert additional pressure on the venous system in the lower extremities and exacerbate venous insufficiency. During rest periods, elevating the legs closer to the heart is recommended because this simple yet effective adjustment promotes venous return and reduces the gravitational burden on the venous valves of the legs. The use of graduated compression stockings during waking hours is another therapeutic lifestyle intervention that is often prescribed for patients with varicose veins. Additional TLCs include maintaining optimal body weight and engaging in regular physical exercise Walking or cycling are often recommended because of their effectiveness in promoting lower limb venous return.
Yongin Severance Hospitall, Yonsei University College of Medicine
Yongin, Gyeonggi-do, South Korea
Change in venous reflux time
The investigators will assess the changes in venous reflux time using lower limb venous Doppler ultrasound examinations. The examination will be performed by an independent assessor who is not aware of the group assignments to ensure unbiased assessment and measurement.
Time frame: 6, 12 weeks
Improvement of venous reflux
The investigators will assess the improvement of venous reflux of target vessel (superficial vein \< 0.5 seconds, deep vein \< 1 seconds)
Time frame: 6, 12 weeks
Change in varicose vein size area
The investigators will assess changes in varicose vein diameters using lower-limb venous Doppler ultrasound examinations
Time frame: 6, 12 weeks
Change in venous reflux volume
The investigators will assess the changes in venous reflux volume using Venous Doppler Reflux VTI × varicose vein size area
Time frame: 6, 12 weeks
Change of extracellular water ratio
The investigators will assess the changes in extracellular water (ECW) ratio (ECW/total body water) of target limb using body composition analyzer (ACCUNIQ BC720®).
Time frame: 6, 12 weeks
Improvement in Venous Clinical Severity Score (VCSS)
The Venous Clinical Severity Score (VCSS) assesses the severity of chronic venous diseases. The score ranges from 0 (no symptoms) to 30 (severe venous disease). The scoring system considers various factors, including pain; varicose veins; venous edema; skin pigmentation; inflammation; induration; and active ulcers and their duration, size, and number. A higher VCSS indicates a worse outcome, implying a more severe state of venous disease.
Time frame: 6, 12 weeks
Improvement of 14-item Chronic Venous Insufficiency quality of life Questionnaire (CIVIQ-14)
The Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ-14) is a valuable tool designed to evaluate the impact of chronic venous insufficiency on quality of life. Improvement in the CIVIQ-14 refers to the enhancement in scores, indicating better management of symptoms, greater comfort, and overall well-being of the patient over the course of treatment or intervention.
Time frame: 6, 12 weeks
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